Tuesday, October 20, 2015

Version 2 of the Diagnostic Test Working Group Proposal is Circulating

According to the subscription trade journal Inside Health Policy, the Diagnostic Test Working Group (DTWG) is circulating a revised version of its plan for FDA reform and a new paradigm for diagnostics regulation. Inside Health Policy also suggests (here) a potential House Energy & Commerce hearing on laboratory tests for October 29, 2015, although this is not publicly calendared at the House website yet. The hearing was held in November, my blog here.

Inside Health Policy on the revised DTWG plan, subscription, here. On the Senate side, Inside Health Policy suggests the possibility of standalone diagnostics regulation that would not be part of 21st Century Cures or its Senate equivalent (here).

The DTWG does not maintain a website or provide easily accessible versions of its proposals. In late September, the trade journal Genomeweb published a long article that assessed the competing approaches to LDT regulation from FDA, CAP, AMP, and DTWG (here). See also Genetic Engineering News, 10/2015, here.

As previously reported by Inside Health Policy, Theranos recently hired lobbyists to advocate for FDA regulation of LDTs. While sources told IHP the company was initially lobbying in support of a proposal from the Diagnostic Test Working Group, a working group of large reference laboratories and manufacturers, Theranos denied these claims.

"Theranos is not lobbying in support of the DTWG proposal.

With regard to LDT quality and the FDA, we believe that doctors and patients deserve results they can trust as they make some of the most important decisions of their lives. We believe it is critical that quality standards for lab tests not be compromised. We also believe that ensuring every company and every lab can operate on a level playing field with transparent, consistent, clearly defined standards and regulations," a spokesperson for the company told IHP at the time.

About the Author

Bruce Quinn MD PhD is an expert on health reform, innovation, and Medicare policy. He helps both large and small companies understand and overcome hurdles to commercialization, as well as craft business strategies for a changing environment. CONTACT Dr. Quinn through www.brucequinn.com. BACKGROUND: Dr. Quinn has worked in academic medicine, Accenture business strategies, and for the Medicare program. EDUCATION: Stanford MD/PhD, MIT Postdoc, Kellogg MBA.